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Real-life Dual-Task Training for Older Adults at Risk to Fall: A Pilot Clinical Trial (REAL-DTT)

2026年11月5日 更新者:Colorado State University

Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaning that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall compared to fall prevention education.

研究概览

研究类型

介入性

注册 (估计的)

68

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Colorado
      • Fort Collins、Colorado、美国、80524

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ≥65 years old
  • fall risk identified from one of the Centers for Disease Control STEADI Three Key Questions Screen
  • ambulatory in the home with or without an assistive device
  • fluent in English

Exclusion Criteria:

  • clinically meaningful cognitive impairment as evidenced by Montreal Cognitive Assessment Score screening
  • unstable cardiac condition (e.g., unstable angina, acute myocarditis, acute pericarditis)
  • acute systemic infection
  • active cancer treatment
  • prisoners
  • unable or unwilling to attend assessment or intervention sessions (Colorado State University)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Real-life Dual-Task Training

Six real-life dual-task training sessions with explicit focus on motor and cognitive components of instrumental activities of daily living. Training occurs with a licensed occupational therapist, and activity selection and grading is guided by the therapist and participant.

The intervention is Real-life Dual-Task Training (Real-DTT) which uses instrumental activities of daily living training with explicit focus on the cognitive and motor elements and progressive complexity. A structured debrief is used to determine when to focus attention on cognitive vs. motor tasks in order to reduce fall risk. The Real-DTT sessions will be delivered once a week for 6 weeks and delivered by a licensed occupational therapist. Real-DTT is a modified version of occupational therapy, with a protocol tailored to the participants.

有源比较器:Fall Prevention Education

Six guided fall prevention education sessions combining evidence-based fall prevention topics, CDC patient fall prevention handouts, NIH/NCOA fall prevention education resources, and tailored discussion utilizing behavior-change techniques.

Guided fall prevention education combining evidence-based fall prevention topics, CDC patient fall prevention handouts, NIH/NCOA fall prevention education resources, and tailored discussion utilizing behavior-change techniques.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cognitive Dual-Task Effect
大体时间:Baseline, week 6-7, week 12-14

Cognitive Dual-task Effect is a percent change from single to dual-tasking: ([dual-task-singletask]/single-task) *100. The cognitive condition is verbal fluency. The dual-task condition combines verbal fluency (cognitive) through the Timed Up & Go dual task.

Baseline, week 6-7, week 12-14
Motor Dual-Task Effect
大体时间:Baseline, week 6-7, week 12-14

Motor Dual-task Effect is calculated as a motor percent changes from single to dual-tasking: ([dual-task-singletask]/single-task) *100. The percent change calculates the difference in time in seconds to complete the Timed Up & Go from single to dual-task.

Baseline, week 6-7, week 12-14

次要结果测量

结果测量
措施说明
大体时间
Performance-Based Assessment of Self-Care Skills
大体时间:Baseline, week 6-7, week 12-14

The Performance-Based Assessment of Self-Care Skills (PASS) is a performance-based measure of activity performance. The PASS is validated for individual instrumental activities of daily living (IADLs) and therefore we will use the 14 physical emphasis IADLs, and the 4 cognitive emphasis IADLs.

Baseline, week 6-7, week 12-14
Activities-Specific Balance Confidence Scale
大体时间:Baseline, week 6-7, week 12-14

A standardized 16-item self-report measure of balance confidence, scores range from 0-100% with higher scores indicating greater confidence in balance when performing various functional activities.

Baseline, week 6-7, week 12-14
Acceptability of Intervention Measure
大体时间:week 12-14

The Acceptability of Intervention Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater acceptability.

week 12-14
Intervention Appropriateness Measure
大体时间:week 12-14

The Intervention Appropriateness Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater appropriateness.

week 12-14
Feasibility of Intervention Measure
大体时间:week 12-14

The Feasibility of Intervention Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater feasibility.

week 12-14

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2028年8月30日

研究完成 (估计的)

2028年8月30日

研究注册日期

首次提交

2026年10月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 8483
  • R21AG095443 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

At the study completion, de-identified (i.e., not including name, or any identifying information) demographic data, health information data, self-reported falls data, and performance-based assessment data will be preserved to enable sharing on a repository for transparency and per NIH sharing agreements.

IPD 共享时间框架

Reviewed by NACDA after study completion, data de-identification, and posting. Then NACDA maintains archives permanently.

IPD 共享访问标准

NACDA's curation staff performs a reidentification risk and harm risk review of all data to ensure confidentiality is protected in released datasets. Data cleared for public access have minimal reidentification and harm risk, and therefore, no restrictions on access.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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